U.S. patent number 7,410,495 [Application Number 11/103,056] was granted by the patent office on 2008-08-12 for medical closure clip system and method.
This patent grant is currently assigned to KCI Licensing, Inc.. Invention is credited to David S. Zamierowski.
United States Patent |
7,410,495 |
Zamierowski |
August 12, 2008 |
Medical closure clip system and method
Abstract
A medical closure screen device for a separation of first and
second tissue portions is provided, which includes a mesh screen
comprising tubular vertical risers, vertical strands with barbed
filaments, and horizontal spacers connecting the risers and strands
in a grid-like configuration. An optional perimeter member partly
surrounds the screen and can comprise a perimeter tube fluidically
coupled with the vertical risers to form a tubing assembly. Various
input/output devices can optionally be connected to the perimeter
tube ends for irrigating and/or draining the separation according
to methodologies of the present invention. Separation closure,
irrigation and drainage methodologies are disclosed utilizing
various combinations of closure screens, tubing, sutures, fluid
transfer elements and gradient force sources. The use of mechanical
forces associated with barbed strands for repositionably securing
separated tissues together is disclosed. The use of same for
eliminating or reducing the formation of subcutaneous voids or
pockets, which can potentially form hematoma and seroma effects, is
also disclosed. The device can be fabricated and the method
practiced with clips having various configurations.
Inventors: |
Zamierowski; David S. (Shawnee
Mission, KS) |
Assignee: |
KCI Licensing, Inc. (San
Antonio, TX)
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Family
ID: |
46304325 |
Appl.
No.: |
11/103,056 |
Filed: |
April 11, 2005 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20050234510 A1 |
Oct 20, 2005 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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10224852 |
Aug 21, 2002 |
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Current U.S.
Class: |
606/216 |
Current CPC
Class: |
A61B
17/064 (20130101); A61B 17/08 (20130101); A61B
2217/005 (20130101); A61B 2017/06176 (20130101); A61B
2017/081 (20130101); A61B 2017/00004 (20130101) |
Current International
Class: |
A61B
17/08 (20060101); A61D 1/00 (20060101) |
Field of
Search: |
;606/213,215,216,221
;256/2,6-9 ;140/50 ;24/112,3.13,369,299,371,343,380 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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550575 |
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Aug 1982 |
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AU |
|
745271 |
|
Apr 1999 |
|
AU |
|
755496 |
|
Feb 2002 |
|
AU |
|
2005436 |
|
Jun 1990 |
|
CA |
|
26 40 413 |
|
Mar 1978 |
|
DE |
|
43 06 478 |
|
Sep 1994 |
|
DE |
|
295 04 378 |
|
Oct 1995 |
|
DE |
|
0100148 |
|
Feb 1984 |
|
EP |
|
0117632 |
|
Sep 1984 |
|
EP |
|
0161865 |
|
Nov 1985 |
|
EP |
|
0358 302 |
|
Mar 1990 |
|
EP |
|
1 018 967 |
|
Aug 2004 |
|
EP |
|
692578 |
|
Jun 1953 |
|
GB |
|
2 197 789 |
|
Jun 1988 |
|
GB |
|
2 200 357 |
|
Jan 1990 |
|
GB |
|
2 220 357 |
|
Jan 1990 |
|
GB |
|
2 235 877 |
|
Mar 1991 |
|
GB |
|
2 235 877 |
|
Mar 1991 |
|
GB |
|
2333965 |
|
Aug 1999 |
|
GB |
|
2329127 |
|
Aug 2000 |
|
GB |
|
4129536 |
|
Apr 1992 |
|
JP |
|
71559 |
|
Apr 2002 |
|
SG |
|
WO80/02182 |
|
Oct 1980 |
|
WO |
|
WO 80/02182 |
|
Oct 1980 |
|
WO |
|
WO 93/09727 |
|
May 1993 |
|
WO |
|
WO 94/20041 |
|
Sep 1994 |
|
WO |
|
WO96/05873 |
|
Feb 1996 |
|
WO |
|
WO97/18007 |
|
May 1997 |
|
WO |
|
WO 99/13793 |
|
Mar 1999 |
|
WO |
|
Other References
Mendez-Eastman, Susan. When Wounds Won't Heal. RN. Jan. 1998, pp.
20-24. cited by examiner .
Orringer, Jay, et al; "Management of Wounds in Patients with
Complex Enterocutaneous Fistulas"; Surgery, Gynecology &
Obstertrics, Jul. 1987, vol. 165, pp. 79-80. cited by other .
International Search Report for PCT International Application
PCT/GB95/01983; Nov. 23, 1995. cited by other .
PCT International Search Report for PCT International Application
PCT/GB98/02713; Jan. 8, 1999. cited by other .
PCT Written Opinion; PCT International Application PCT/GB98/02713;
Jun. 8, 1999. cited by other .
PCT International Examination and Search Report, PCT International
Application PCT/GB96/02802; Jan. 15, 1998 & Apr. 29, 1997.
cited by other .
PCT Written Opinion, PCT International Application PCT/GB96/02802;
Sep. 3, 1997. cited by other .
Dattilo, Philip P., Jr., et al; "Medical Textiles: Application of
an Absorbable Barbed-Bi-directional Surgical Suture"; Journal of
Textile and Apparel, Technology and Management, vol. 2, Issue 2,
Spring 2002; pp. 1-5. cited by other .
Kostyuchenok, B.M., et al; "Vacuum Treatment in the Surgical
Management of Purulent Wounds"; Vestnik Khirurgi, Sep. 1986; pp.
18-21, and 6 page English translation thereof. cited by other .
Davydov, Yu. A., et al; "Vacuum Therapy in the Treatment of
Purulent Lactation Mastitis"; Vestnik Khirurgi, May 14, 1986; pp.
66-70, and 9 page English translation thereof. cited by other .
Yusupov. Yu. N., et al; "Active Wound Drainage", Vestnik Khirurgi,
vol. 138, Issue 4, 1987, and 7 page English translation thereof.
cited by other .
Davydov, Yu. A., et al; "Bacteriological and Cytological Assessment
of Vacuum Therapy for Purulent Wounds"; Vestnik Khirurgi, May 2,
1986; pp. 42-46, 7 page English translation thereof. cited by other
.
Davydov, Yu. A., et al; "Concepts for the Clinical-Biological
Management of Wound Process in the treatment of Purulent Wounds by
Means of Vacuum Therapy"; Vestnik Khirurgi, Jul. 7, 1980; pp.
132-136, and 8 page English translation thereof. cited by other
.
Louis C. Argenta, MD and Michael J. Morykwas, PhD; "Vaccum-Assisted
Closure: A New Method for Wound Control and Treatment: Clinical
Experience"; Annals of Plastic Surgery, vol. 38, No. 6, Jun. 1997;
pp. 563-576. cited by other .
Susan Mendez-Eastmen, RN; "When Wounds Won't Heal" RN Jan. 1998,
vol. 61 (1); Medical Economics Company, Inc., Montvale, NJ, USA;
pp. 20-24. cited by other .
James H. Blackburn, II, MD, et al; "Negative-Pressure Dressings as
a Bolster for Skin Grafts"; Annals of Plastic Surgery, vol. 40, No.
5, May 1998, pp. 453-457. cited by other .
John Masters; Reliable, Inexpensive and Simple Suction Dressings:;
Letter to the Editor, British Journal of Plastic Surgery, 1998,
vol. 51 (3), p. 267; Elsevier Science/The British Association of
Plastic Surgeons, UK. cited by other .
S.E. Greer, et al "The Use of Subatmospheric Pressure Dressing
Therapy to Close Lymphocutaneous Fistulas of the Groin" Britsh
Journal of Plastic Surgery (2000), 53, pp. 484-487. cited by other
.
George V. Letsou, MD., et al; "Stimulation of Adenylate Cyclase
Activity in Cultured Endothelial Cells Subjected to Cyclic
Stretch"; Journal of Cardiovascular Surgery, 31, 1990, pp. 634-639.
cited by other.
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Primary Examiner: Manahan; Todd E.
Assistant Examiner: Gettman; Christina D
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of U.S. patent
application Ser. No. 10/224,852 filed on Aug. 21, 2002 currently
pending in the United States Patent Office, and is incorporated
herein by reference.
Claims
Having thus described the invention, what is claimed as new and
desired to be secured by Letters Patent is:
1. A medical closure method for internally closing a separation
between first and second tissue portions with opposed first and
second tissue edges, which method comprises the steps of: providing
multiple clips wherein each clip comprises a length of wire bent to
form first and second prongs and first and second loops in each
clip; interconnecting respective first and second loops of adjacent
clips and thereby forming multiple, flexible strands each
comprising multiple interconnected clips; maintaining said first
prongs of said interconnected clips in a first orientation and
maintaining said second prongs of said interconnected clips in a
second orientation by said interconnected loops: positioning said
multiple strands in generally parallel, juxtaposed relation:
forming a flexible screen by providing multiple, flexible
filaments, extending said filaments transversely or diagonally
across said juxtaposed strands and connecting said filaments to
said strands; presenting opposite first and second screen faces and
a screen distal edge; extending a first set of clip prongs from
said first screen face towards said screen distal edge; extending a
second set of clip prongs from said second screen face towards said
screen distal edge; forming an acute angle between each said clip
prong and a respective screen face: placing said screen in said
tissue separation between said opposed tissue edges; penetrating
said first tissue edge with said first set of prongs: generally
approximating said tissue edges; penetrating said second tissue
edge with said second set of prongs; pulling said screen distal
edge distally; further embedding said prongs in said tissue edges
respectively; and further approximating said tissue edges.
2. A medical closure method for internally closing a separation
between first and second tissue portions with opposed first and
second tissue edges, which method comprises the steps of: providing
multiple clips wherein each said clip has; with a planar body
having first and second faces and a perimeter; and having a prong
formed from said clip body; aligning multiple said clips; flexibly
interconnecting said multiple aligned clips to form a flexible
strand; forming multiple said strands; positioning said multiple
strands in generally parallel, juxtaposed relation; forming a
flexible screen by providing multiple, flexible filaments,
extending said filaments transversely or diagonally across said
juxtaposed strands and connecting said filaments to said strands;
presenting opposite first and second screen faces and a screen
distal edge; angling a first set of said clip prongs from said
first screen face towards said screen distal edge; angling a second
set of said clip prongs from said second screen face towards said
screen distal edge; forming an acute angle between each said clip
prong and a respective screen face; placing said screen in said
tissue separation between said opposed tissue edges; penetrating
said first tissue edge with said first set of prongs; generally
approximating said tissue edges; penetrating said second tissue
edge with said second set of prongs; pulling said screen distal
edge distally; further embedding said prongs in said tissue edges
respectively; and further approximating said tissue edges.
3. A medical closure method for internally closing a separation
between first and second tissue portions with opposed first and
second tissue edges, which method comprises the steps of: providing
multiple clips; each said clip having a prong; aligning multiple
said clips; flexibly interconnecting multiple aligned clips;
forming multiple, flexible strands each comprising multiple
interconnected clips; positioning said multiple strands in
generally parallel, juxtaposed relation; forming a flexible screen
by providing multiple, flexible filaments, extending said filaments
transversely or diagonally across said juxtaposed strands and
connecting said filaments to said strands; presenting opposite
first and second screen faces and a screen distal edge; angling a
first set of clip prongs outwardly from said first screen face
towards said screen distal edge; angling a second set of clip
prongs outwardly from said second screen face towards said screen
distal edge; forming an acute angle between each said clip prong
and a respective screen face; placing said screen in said tissue
separation between said opposed tissue edges; penetrating said
first tissue edge with said first set of prongs; generally
approximating said tissue edges; penetrating said second tissue
edge with said second set of prongs; extending said screen distal
edge distally beyond a skin surface at said first and second tissue
portions; pulling said screen distal edge distally; tensioning said
screen; further embedding said prongs in said tissue cdges
respectively; further approximating said tissue edges; anchoring
said screen extended distal cdge to said skin surface at said
closed tissue portions; fluidically connecting a hydrophobic foam
material to said screen extended distal edge at said skin surface;
draping said foam material and the surrounding skin surface;
applying a negative pressure to said foam material through said
drape; approximating said tissue portions at said skin surface with
said negative pressure; and draining said wound via said foam
material with said negative pressure.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical (including
dental, veterinary, etc.) closure and wound fluid management
devices, and in particular to a screen closure member for closing
tissue separations, such as incisions and wounds, which closure
member is optionally bioabsorbable. The closure member can be
assembled with different components chosen for their functional and
material compatibility characteristics.
2. Description of the Prior Art
In the medical field, which is broadly defined to include
dentistry, veterinary medicine, etc., cutaneous incisions are
commonly performed in surgery to provide access to underlying
tissue, organs, joints, skeletal structure, etc. Incision and
closure techniques are an important part of surgery in general.
They tend to occupy surgical teams and other resources for
significant portions of many surgical procedures.
Surgeons generally strive to minimize the traumatic and scarring
effects of surgery on their patients by both minimizing the
incisions, and by employing a variety of closure techniques which
tend to reduce postoperative swelling, bleeding, seroma, infection
and other undesirable postoperative side effects. For example, the
fields of endoscopic-assisted surgery, microscopic surgery, and
computer-enhanced instrumentation (e.g., the DaVinci System
available from Intuitive Surgical, Inc. of Sunnyvale, Calif.) are
generally concerned with minimally invasive surgery ("MIS")
procedures and techniques, which have proven to be increasingly
popular. Such popularity is at least partly due not only to the
minimally-sized scars left by such techniques, but also to the
minimal trauma to the fascia and muscle layers and the
correspondingly faster recoveries this allows. However, surgeons
must balance such considerations with providing adequate access to
perform various surgical procedures. A typical surgical procedure
involves a cutting or dissecting phase and a closing phase. In
recent years, considerable progress has been made in minimizing
surgical cutting, dissecting and shaping. Surgical closing
techniques involve sutures, clips, staples and adhesives. However,
suturing can be time-consuming and tedious. Moreover, the tissue
structures to be joined may not be amenable to other closure
techniques. MIS often restricts access to the separated tissue
structures, thus making it more difficult to approximate and close
same.
In contrast to MIS, some surgical procedures, by their nature, must
include long incisions. Examples include cutaneous excisional
procedures such as "lifts" and reduction procedures, flap
procedures for closure of defects, and many bariatric procedures.
Suturing in these extensive defects can be time-consuming and
tedious.
The "first intention" (primary intention healing) in surgery is to
"close" the incision. For load-bearing tissues, such as bone,
fascia, and muscle, this requires substantial material, be it
suture material, staples, or plates and screws. For the wound to be
"closed," the epithelial layer must seal. To accomplish this, the
"load bearing" areas of the cutaneous and subcutaneous layers
(i.e., the deep dermal elastic layer and the superficial fascia or
fibrous layers of the adipose tissue, respectively) must also at
least be held in approximation. Important considerations include
controlling infection and bleeding, reducing scarring, eliminating
the potential of hematoma, seroma, and "dead-space" formation and
managing pain. Dead-space problems are more apt to occur in the
subcutaneous closure. Relatively shallow incisions can normally be
closed with surface-applied closure-techniques, such as sutures,
staples, glues, and adhesive tape strips. However, deeper incisions
may well require not only skin surface closure, but also
time-consuming placement of multiple layers of sutures in the
load-bearing planes. Absorbable sutures are commonly used for this
purpose and comprise an important class of surgical sutures.
Depending on various factors, absorbable sutures typically dissolve
over a period of a few days to a few months. Commercially available
examples include Monocryl.RTM. monofilament absorbable synthetic
sutures comprising a poliglecaprone and PDS.RTM. (polydrioxanone)
and Vicryl.RTM. (polyglactin) sutures, all available from Ethicon,
Inc., of Somerville, N.J.
Surgical mesh is commonly used to span or reinforce load-bearing
planes or defects in them. When coupled with sutures or fasteners,
surgical mesh represents another important class of surgical
closure devices. Applications include reconstruction, hernia
repair, and organ repair. In such procedures, surgical mesh fabric
prostheses are inserted into patients through either open surgery
or endoscopic (MIS) procedures. Knitted surgical mesh for hernia
repair is disclosed in the Agarwal et al. U.S. Pat. No. 6,287,316,
which is assigned to Ethicon, Inc. Another Ethicon, Inc. patent,
Duncan U.S. Pat. No. 4,548,202, discloses mesh tissue fasteners
including various fastening members with spaced-apart legs for
passing through tissue portions. Another closure procedure involves
the placement of pins or rods through skin edge or bone followed by
the placement of an external clamp or fixator device spanning the
wound and frequently incorporating a worm-screw apparatus capable
of progressive tightening over time to effect closure,
stabilization or distraction.
Fluid management represents another important aspect of both open
and minimally invasive surgery. Postoperative fluid drainage can be
accomplished with various combinations of tubes, sponges, and
porous materials adapted for gathering and draining bodily fluids.
The prior art includes technologies and methodologies for assisting
drainage. For example, the Zamierowski U.S. Pat. Nos. 4,969,880;
5,100,396; 5,261,893; 5,527,293; and U.S. Pat. No. 6,071,267
disclose the use of pressure gradients, i.e., vacuum and positive
pressure, to assist with fluid drainage from wounds, including
surgical incision sites. Such pressure gradients can be established
by applying porous foam material either internally or externally to
a wound, covering same with a permeable, semi-permeable, or
impervious membrane, and connecting a suction vacuum source
thereto. Fluid drawn from the patient is collected for disposal.
Such fluid control methodologies have been shown to achieve
significant improvements in patient healing. Another aspect of
fluid management, postoperative and otherwise, relates to the
application of fluids to wound sites for purposes of irrigation,
infection control, pain control, growth factor application, etc.
Wound drainage devices are also used to achieve fixation and
immobility of the tissues, thus aiding healing and closure. This
can be accomplished by both internal closed wound drainage and
external vacuum devices. Fixation of tissues in apposition can also
be achieved by-bolus tie-over dressings (Stent dressings), taping,
strapping and (contact) casting.
Heretofore, there has not been available a medical closure screen
assembly with the advantages and features of the present invention,
including the combination of same with negative pressure wound
therapy ("NPWT").
SUMMARY OF THE INVENTION
In the practice of one aspect of the present invention, a medical
closure screen device is provided, which includes a mesh screen
comprising tubular vertical risers, barbed filaments therebetween
and horizontal spacers. Integral or separate sutures can be
provided. An optional perimeter member partly surrounds the screen
member and can comprise a perimeter tube fluidically coupled with
the vertical risers to form a tubing assembly. The tubing assembly
cooperates with the vertical risers to extract fluid from the
tissue separation in a drain mode and to introduce fluid thereinto
in an irrigate mode. In one embodiment of the invention the tubing
assembly is fluidically coupled to a vacuum source to facilitate
drainage. In another embodiment of the invention, the perimeter
tube is passed through the surrounding tissue to secure the screen
member in place. Fluid transfer elements, such as sponges, foams,
absorbent mesh, microtubular materials and the like, are optionally
placed adjacent to and over an extension of the screen for fluid
transfer, for example, in conjunction with a vacuum or pump source.
Another embodiment of the invention includes a suture connected to
the screen and adapted for securing same in a tissue
separation.
Alternative embodiment vertical risers are also disclosed, and can
provide active fluid transfer utilizing the patient's body
dynamics. Yet another alternative embodiment of the present
invention utilizes the screen barbs for mechanical fixation in a
separation for closure of same. Separation closure, irrigation and
drainage methodologies are disclosed utilizing various combinations
of closure screens, tubing, sutures, fluid transfer elements and
gradient force sources. The closure screen of the present invention
uses mechanical and other forces associated with screens and barbed
strands for securing separated tissues together and for eliminating
or reducing the formation of subcutaneous voids or pockets, which
can potentially form hematoma and seroma effects. Further
embodiments of the invention include assemblies of clips, which can
comprise relatively rigid material, with flexible, elastic or
collapsible connecting filaments forming composite material
screens.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view of a medical closure screen
device embodying the present invention.
FIG. 2 is an enlarged, fragmentary, side elevational view thereof,
taken generally within circle 2 in FIG. 1.
FIG. 3 is an enlarged, fragmentary, side elevational view thereof,
taken generally along line 3-3 in FIG. 2, and particularly showing
a barbed strand.
FIGS. 4a-f show alternative perimeter tube end closures comprising:
4a) subdermal termination; 4b) knotted end; 4c) Leur lock; 4d)
transfer element (i.e., sponge); 4e) vacuum source; and 4f) clamped
end.
FIGS. 5a-e show a tissue separation closure procedure embodying the
method of the present invention.
FIG. 6a is an enlarged, fragmentary, cross-sectional view of the
closure screen in a tissue separation, with skin hooks shown in
hidden lines for positioning the separated tissue portions along
the closure screen.
FIG. 6b is an enlarged, fragmentary, cross-sectional view of the
closure screen in a substantially closed tissue separation.
FIGS. 7a-f show a tissue separation closure procedure embodying the
method of the present invention and utilizing optional sponge or
foam fluid transfer elements and a tubing placement tool.
FIG. 8 is a cross-sectional view of a tissue separation closure
utilizing tubing for securing the closure screen with a fluid
transfer subassembly connected to an upper edge of the closure
screen.
FIG. 9 shows a needle mounting a length of drain tubing and adapted
for passing same through tissue.
FIG. 10 is a side elevational view of a closure screen comprising
an alternative embodiment of the present invention, with a
perimeter suture.
FIG. 11a is an enlarged, fragmentary, side elevational view
thereof, taken generally within circle 11a in FIG. 10.
FIG. 11b is an enlarged, fragmentary, side elevational view
thereof, showing modified vertical risers.
FIG. 12 is a side elevational view of a screen-only closure screen
comprising an alternative embodiment of the present invention.
FIG. 13a is an enlarged, fragmentary, side elevational view
thereof, taken generally within circle 13a in FIG. 12.
FIG. 13b is an enlarged, fragmentary, side elevational view
thereof, showing modified vertical risers.
FIGS. 14a-g show a tissue separation closure procedure utilizing
the screen-only embodiment of the closure screen.
FIG. 15a is a side elevational view of a modified vertical riser
with flexible, multi-tube risers forming a fluid passage.
FIG. 15b is a cross-sectional view thereof, taken generally along
line 15b-15b in FIG. 15a.
FIG. 16a is a fragmentary, side elevational view thereof, shown in
a compressed configuration.
FIG. 16b is a cross-sectional view thereof, taken generally along
line 16b-16b in FIG. 16a.
FIG. 17 is a cross-sectional view of another modified vertical
riser construction with risers bundled in a different
configuration, with barbs.
FIG. 18 is a cross-sectional view of a modified vertical riser or
perimeter element, comprising a fluted tube.
FIG. 19 is an enlarged, fragmentary, side elevational view of a
modified barbed strand configuration.
FIG. 20 is an enlarged, fragmentary, side elevational view of
another modified barbed strand configuration.
FIG. 21 is an enlarged, cross-sectional view of a closure screen
comprising an alternative embodiment of the present invention, with
barbs formed by cutting off the ends of looped filaments.
FIG. 22 is an enlarged, cross-sectional view of a closure screen
comprising an alternative embodiment of the present invention, with
barbs forming hooks and constructed by cutting looped
filaments.
FIG. 23 is an enlarged, cross-sectional view of a closure screen
comprising yet another alternative embodiment of the present
invention, with barbs formed by cutting off the ends of looped
filaments, which are laid over in a common direction or
orientation.
FIG. 24 is an enlarged, cross-sectional view of a closure screen
comprising a further alternative embodiment of the present
invention, with barbs forming hooks and constructed by cutting
looped filaments, which are laid over in a common direction or
orientation.
FIG. 25 is a perspective view of a closure screen comprising a
further alternative embodiment or aspect of the invention,
comprising individual links forming flexible strands.
FIG. 25a is a front elevational view of a link thereof.
FIG. 26 is a side elevational view of an alternative configuration
link for the closure screen shown in FIG. 25.
FIG. 27 is a front elevational view thereof.
FIG. 27a is a front elevational view of an alternative
configuration link for the closure screen shown in FIG. 25.
FIG. 28 is a side elevational view of a strand thereof.
FIG. 29 is a side elevational view of the strand, shown
compressed.
FIG. 30 is an enlarged, cross-sectional, fragmentary view of the
strand approximating separated tissue portions.
FIG. 31 is a side elevational view of a link of a strand of another
alternative embodiment closure screen system.
FIG. 32 is a front elevational view thereof.
FIG. 33 is a fragmentary, side elevational view of a strand
thereof.
FIG. 34 is a perspective view of another alternative embodiment of
the closure screen system, including individual clips mounted on
flexible strips.
FIG. 34a shows perspective views of alternative clip
configurations.
FIG. 35 is a side elevational view showing a clip approximating
opposing tissue portions edges, taken generally along line 35 in
FIG. 34a.
FIG. 36 is a perspective view of another alternative embodiment of
the closure screen system including individual clips.
FIG. 37 is a side elevational view of an individual clip thereof,
taken generally along line 37 in FIG. 36.
FIG. 38 shows perspective views of alternative fastening clip
constructions for use in conjunction with the present
invention.
FIG. 39 shows another fastening clip construction, which is
attached to a mesh.
FIGS. 40-43 are side elevational views of various clip-type closure
screens.
FIGS. 44-46 are perspective views of wire fastening clips for use
in conjunction with the present invention.
FIGS. 47-49 are side elevational views of the clips shown in FIGS.
44-46 respectively.
FIG. 50 is a plan view of another alternative embodiment clip
configuration.
FIGS. 51a-c show alternative prong orientations for the clip
configurations shown in FIG. 50.
FIGS. 52a-c are side elevational views of the clips shown in FIGS.
51a-c.
FIG. 53 is a side elevational view of another alternative
embodiment clip, with curved prongs.
FIG. 53a is a side elevational view of the clip shown in FIG. 53,
shown approximating separated tissue.
FIG. 54 is a side elevational view of another alternative
embodiment clip, with a curved body.
FIG. 54a is a side elevational view of the clip shown in FIG. 54,
shown anchored in tissue.
FIG. 55 is a side elevational view of another alternative
embodiment closure screen, with clip prongs thereof shown folded
substantially flat with respect to the clip bodies, and backing
material placed on both sides of the closure screen.
FIG. 55a is a side elevational view of the closure screen shown in
FIG. 55, with the clip prongs extended and anchored in tissue along
one side.
FIGS. 56-58 show alternative embodiment prongs.
FIG. 59 shows an alternative embodiment closure system with
external attachments and an optional negative pressure source.
FIG. 60 is a graph showing a load-deformation curve (tension in
relation to extension) for a test involving a screen comprising
multiple clips and embodying the present invention.
FIG. 61 is a graph showing another load deformation curve
(compression in relation to extension) for another test involving
the multiple-clip screen.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
I. Introduction and Environment
As required, detailed embodiments of the present invention are
disclosed herein; however, it is to be understood that the
disclosed embodiments are merely exemplary of the invention, which
may be embodied in various forms. Therefore, specific structural
and functional details disclosed herein are not to be interpreted
as limiting, but merely as a basis for the claims and as a
representative basis for teaching one skilled in the art to
variously employ the present invention in virtually any
appropriately detailed structure.
Certain terminology will be used in the following description for
convenience in reference only and will not be limiting. For
example, the words "upwardly", "downwardly", "rightwardly" and
"leftwardly" will refer to directions in the drawings to which
reference is made. The words "inwardly" and "outwardly" will refer
to directions toward and away from, respectively, the geometric
center of the embodiment being described and designated parts
thereof. The words "horizontal" and "vertical" generally mean
side-to-side and top-to-bottom, respectively. Said terminology will
include the words specifically mentioned, derivatives thereof and
words of a similar import.
Referring to the drawings in more detail, the reference numeral 2
generally designates a medical closure screen device or system
embodying the present invention. Without limitation on the
generality of useful applications of the closure screen system 2,
the primary application disclosed herein is for assistance with the
closing, draining, irrigating and healing of a separation of first
and second tissue portions, such as a wound or incision 4. As shown
in FIG. 5a, the wound 4 extends from and is open at the dermis 6,
through the deep dermal layer 7 and the subcutaneous layer 8, and
to approximately the fascia 10. The wound 4 displays edges 12a,b,
which correspond to first and second tissue portions. The closure
screen device 2 generally comprises a screen 14, a screen perimeter
member 16 and an input/output (I/O) subsystem 18.
II. Screen 14
The screen 14 includes upper and lower margins 20a,b; first and
second ends 22a,b; and first and second faces 24a,b. The screen 14
generally forms a grid configuration with vertical, hollow,
perforated tubular risers 26 cross-connected by horizontal spacer
members 28. Multiple barbed strands 30 are positioned between the
risers 26. The risers 26, the spacers 28 and the strands 30 are
preferably joined at their respective intersections. As shown in
FIG. 3, each strand 30 includes a filament 32 with multiple,
pointed barbs 34 extending upwardly and outwardly on both sides in
staggered, spaced relation. The barbs 34 generally project
outwardly from the screen faces 24a,b, for purposes which will be
described in more detail hereinafter.
The screen or mesh 14 material can be either dissolvable
(absorbable) or non-dissolvable (non-absorbable) and can be chosen
from a number of commercially available, biocompatible products,
which are commonly used in medical applications for sutures,
implantable meshes, and similar medical devices.
Examples of absorbable materials include, but are not limited to:
aliphatic polyesters, which include, but are not limited to:
homopolymers and copolymers of lactide, epsilon-caprolactone,
p-dioxanone, trimethylene carbonate, alkyl derivatives of
trimethylene carbonate, delta-hydroxyvalerate, 1,4-dioxepan-2-one,
1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one and polymer
blends thereof. Examples of nonabsorbable materials include, but
are not limited to: cotton, linen, silk, polyamides, polyesters,
fluoropolymers, polyolefins, polyethylene, metals and combinations
thereof.
III. Screen Perimeter Member 16
The optional screen perimeter member 16 can comprise, for example,
a flexible, perforated, hollow tube 35 with multiple orifices 36.
As shown in FIG. 1, the tube 35 includes first and second legs 38,
40 extending generally along the screen first and second ends
22a,b, and a base leg 41 extending generally along the screen lower
margin 20b. The tubing first and second legs 38, 40 terminate in
respective first and second ends 38a, 40a. The tube 35 can be
secured to the screen 14 by multiple ties 42, which can comprise
extensions of the horizontal spacer members 28 and the strands 30.
By providing dissolvable ties 42, the tube 35 can be designed for
separation from the remainder of the closure screen 2 after a
relatively short period of time. For example, the dissolvable
material can dissolve into the patient's body after a few days,
whereafter the tube 35 can be removed.
Optionally, portions of the tube 35 can be cut away from the screen
14. For example, the screen 14 can be separated along each screen
end 22a,b, or it can be separated completely from the tube 35. In
this manner the screen 14 and the tube 35 can be configured to
accommodate a variety of conditions and tissue separation
configurations.
The vertical risers 26 are optionally fluidically coupled to the
tube 35 at respective T intersections 44. In this configuration the
tube 35 and the vertical risers 26 cooperate to provide a manifold
for fluid handling, i.e. either extraction or irrigation, as
indicated by the fluid flow arrows 45.
IV. Input/Output (I/O) Subsystem 18
The input/output subsystem 18 is designed for extraction and/or
irrigation of the patient's bodily fluids and/or external fluids.
As shown in FIG. 1, the input/output subsystem 18 includes
first-and second I/O devices 18a,b attached to the tubing first and
second leg ends 38a,b, which in this configuration are considered
the "port" ends of the tube 35. One or both of the I/O devices
18a,b can comprise a pressure differential source, such as the NPWT
device. The V.A.C..RTM. System.TM., available from Kinetic
Concepts, Inc. of San Antonio, Tex. The use of such units for wound
treatment and fluid management is disclosed in the Zamierowski U.S.
Pat. Nos. 4,969,880; 5,100,396; 5,261,893; 5,527,293; and U.S. Pat.
No. 6,071,267, which are incorporated herein by reference.
Alternatively, the tubing port ends 38a,b can be connected to
various other sources of pressure differential and various drainage
and irrigation devices. For example, they can be cut short below
the dermis 6 and left within the separation 4 for sealing by the
adjacent tissue portions 12a,b. FIG. 4a shows a truncated tubing
end 38b. The tubing ends 38a/40a can be knotted (as shown at 48 in
FIG. 4b), clipped, tied (e.g., with a suture) or otherwise closed
off either above or below the dermis 6. FIG. 4c shows a Leur lock
coupling 46 mounted on a tubing end 38a/40a. Still further, a
transfer element comprising a piece of foam or sponge 50 can be
coupled to the tube 35 at an end 38a/40a (FIG. 4d). Examples of
such foam and sponge materials and configurations are discussed in
the Zamierowski U.S. patents identified above. A pressure
differential source, such as a vacuum source 51, can be connected
to a tube end 38a/40a and to a fluid receptacle 66, as shown in
FIG. 4e. A clamp 62 is shown in FIG. 4f and closes the tube end
38a/40a. The clamp 62 can be chosen from among several suitable
clamps, which are commonly used for medical applications.
Either tube end 38a/40a can function as either an inlet port or an
outlet port with respect to the system 2. For example, suction can
be applied for pulling fluid from the patient through the system 2
through either tube end 38a/40a. Still further, fluid can be pulled
in both directions through the system 2 by alternately or jointly
applying suction to the tube ends 38a/40a. For example, suction can
be simultaneously applied to both tube ends 38a/40a.
V. Operation and Closure Method
FIGS. 5a-e show an installation methodology utilizing the system 2
of the present invention. In FIG. 5a, the closure screen 2 is
placed in the separation 4 with the tubing base 41 located at the
bottom of the separation (e.g., wound or incision) 4 and in
proximity to the fascia layer 10. As shown, the tissue portions or
wound/incision edges 12a,b are spaced apart. The screen upper
margin 20a can protrude outwardly from the dermis 6. FIG. 5b shows
the tissue separation edges 12 being pushed together as indicated
by the force arrows 52. FIG. 5c shows the separation edges 12
engaged at the dermis 6, and spaced apart somewhat within the
subcutaneous layer 8. The edges 12 can be pushed together as
indicated by the force arrows 52. Moreover, the screen 2 can be
held or positioned inwardly in order to advance the barbs 34 in the
separation edges 12, as indicated by the inward or downward force
arrows 54a. FIG. 5d shows the separation edges 12a,b substantially
closed on the screen 2. Tugging on the screen 14 in the general
direction of the outward force arrow 54b sets the mesh barbs
34.
FIG. 5e shows the separation 4 closed on the closure screen 2, with
the tubing 35 removed from the screen 14. The tubing 35 can be
removed either pre-installation by cutting the ties 42, or
post-installation by allowing the ties 42 to dissolve, whereafter
the unsecured tubing 35 can be extracted.
FIG. 6a shows the barbs 34 compressed by engagement with the
separation edges 12a,b. As shown, the separation edges 12 can be
manually closed by pressing along the horizontal force arrows 52.
The barbs 34 allow the separation edges 12a,b to slide upwardly or
outwardly along the screen 14. This process can be repeated until
the separation 4 is closed, as shown in FIG. 6b. Any protruding
length of the screen 14 can be cut close to the dermis 6. In the
final configuration (FIGS. 5e and 6b), the barbs 34 are embedded in
the tissue adjacent to the separation edges 12a,b and thus secure
the separation 4 in a closed position. The fluid conducting
properties of the screen 14 facilitate extracting fluid. An outward
or upward force arrow 54b indicates a force direction whereby the
screen barbs 34 are set in the adjoining tissue. It will be
appreciated that the screen 14 can be securely set in place with
the barbs 34, yet the separation edges 12a,b will remain capable of
sliding up on the screen 14 by disengaging the barbs 34 with
lateral forces, as shown in FIG. 6a. Skin hooks 55 can be used for
engaging the tissue portions 12a,b and tugging same outwardly as
shown in FIG. 6a. The skin hooks 55 can facilitate positioning and
repositioning the screen 14.
VI. Alternative Embodiment Closure Screen Systems and
Methodologies
FIGS. 7a-f show an alternative procedure for mounting the closure
screen 2 in a wound drainage application utilizing pressure
differential. As shown in FIG. 7a, the tubing 35 can pass through
the tissue adjacent to the wound 4 and exit the dermis 6 for
termination of the tubing end 38a/40a as described above. An
optional layer of a suitable, biocompatible adhesive 64 is shown
applied to the closure screen first face 24a for securing same to
the first wound edge 12a. FIG. 7b shows the screen 14 extending
upwardly from the dermis 6 with the wound edges 12a,b brought
together in a manner similar to that described above.
The input/output subsystem 18 includes a pair of optional fluid
transfer elements comprising foam or sponge members 56a,b placed on
the dermis 6 on either side of a protruding portion 14a of the
screen 14. The screen 14 is then cut to a level generally flush
with the upper surfaces of the sponges 56a,b, as shown in FIG. 7c.
An optional sponge bridge 58 is placed over the sponge members
56a,b (FIG. 7d). Examples of suitable transfer element materials
are discussed in the Zamierowski patents noted above and include
open-cell, porous foam materials (e. g., polyurethane ester (PUE))
chosen for their hydrophobic properties and passage of liquids.
Polyvinyl acetate (PVA) material can be used for its hydrophilic
properties. The transfer element subassembly 59 formed by the
sponge members 56a,b and 58 can be connected to a vacuum source, a
fluid irrigation source, etc. Moreover, it can be connected to
additional fluid transfer elements and covered with various
flexible membranes and drapes, which can be semi-permeable or
impervious, as indicated for the closure and treatment of
particular separations and wounds.
FIG. 7e shows a tubing placement tool 120 with a handle 122, a
shaft 124 and a hook 126 terminating at a pointed or rounded,
bullet-shaped tip 128. FIG. 7f shows the tool 120 passing tubing 35
through tissue in the subcutaneous layer 8 and into proximity with
the dermis 6. The tip 128 is received in a blind end 134 of the
tubing 35 through a notch 136 formed therein. The thrust of the
tool 120 causes tenting of the dermis 6, as shown at 138, whereat
the dermis 6 can be opened with a scalpel 140 and the tubing 35 can
exit the patient for suitable termination arrangements, such as
those shown in FIGS. 4a-f above.
FIG. 8 shows a modified embodiment closure system 202 with a pair
of screens 14 positioned generally end-to-end in a separation 204.
A transfer element subassembly 59 is placed over the separation 204
and a membrane drape 205 is placed thereover. The tube 35 is passed
through tissue on either side of the separation 204 (e.g., using
the procedure and the tubing placement tool 120 described above)
and exits the dermis 6 on either side of the transfer element
subassembly 59. The tube 35 lengths are knotted at 206. The tube 35
lengths thus function as sutures or retainers for securing the
closure system 202 in the separation 204. The tube ends 38a or 40a
can be utilized for this purpose, thus leaving the other tubing
ends available for fluid communication with one or more of the
input/output subsystems 18 described above.
The tube 35 can be secured by suitable fasteners, such as clips and
the like, located above the dermis 6. Moreover, the screens 14 can
be overlapped, abutted, spaced slightly and otherwise configured
and positioned as necessary for particular tissue separations.
Still further, the screens 14 are adapted to be trimmed as
necessary.
FIG. 9 shows a modified embodiment tubing/suture subassembly 220
with a Trocar instrument 222 including a sharpened, distal end 224
and a proximate end 226 with multiple, annular ridges 226a. A
length of flexible tubing 228 combines the functions of screen
perimeter member and suture. The flexible tubing 228 terminates at
an end 228a adapted for releasably mounting on the needle proximate
end 226, whereat it is retained in place by the ridges 226a. The
tubing 228 is optionally connected to the screen 14 as described
above and can include perforations 228b for fluid drainage and/or
irrigation in conjunction with input/output subsystems 18, also as
described above. The tubing/suture subassembly 220 is adapted for
securing the screen 14 in place and for closing the separation 4 by
passing the tubing 228 through adjacent tissue. The tubing/suture
subassembly 220 and the screen 14 can be prepackaged and
presterilized for closing and treating separations, which can
include wounds and incisions.
FIGS. 10, 11a and 11b show modified embodiment closure screen
systems 302 with first and second suture subassemblies 304, 306
comprising the screen perimeter member. The suture subassemblies
304, 306 include respective curved needles 304a, 306a which are
swaged or adhesively connected to opposite ends 304b, 306b of a
common length of suture thread 307. The suture thread 307 can be
absorbable or nonabsorbable. As shown in FIG. 10, the screen
closure system 302 can be preassembled with the suture thread
length 307 releasably secured to the perimeter 308a of a screen
308. Prior to installation of the screen 308, the suture 307 can be
disconnected or severed therefrom, either partly or completely. For
example, the suture 307 can be separated along the screen ends
310a, 310b respectively, thereby leaving the suture thread lengths
secured only along a screen lower margin 312.
In operation, the suture subassemblies 304, 306 facilitate
installation of the suture/screen closure system 302, thereby
providing a preassembled device which incorporates the necessary
components for securing same in a separation 4. For example, the
screen 308 can be secured at the bottom alone by passing the suture
subassemblies 304, 306 through tissue portions located at the
bottom of the separation 4. Alternatively, the suture subassemblies
304, 306 can be passed through the adjacent tissue and exit the
surface of the dermis 6, whereby the suture subassemblies 304, 306
can be used for closing the separation 4 at the dermis 6. Barbed
strands 320 can interact with the tissue portions 12a,b as
described above, whereby the screen 308 provides a relatively
secure mechanical connection between the separated tissue portions
12a,b. The suture subassemblies 304, 306 can be utilized for
various purposes in the separation 4, including attachment and
tacking of the dermis 6, the deep dermal layer 7, the subcutaneous
layer 8 and the fascia 10. Still further, all or part of the suture
subassemblies 304, 306 can be removed, and additional suture
subassemblies can be mounted on or sutured to the screen 308.
FIG. 11a shows the screen 308 attached to the suture thread 307.
FIG. 11b shows an alternative construction screen 318 with hollow
tubular vertical risers 324 located between adjacent, respective
vertical strands 320, all connected by the spacers 322 and adapted
for communicating fluid with the separation 4 through the open
riser ends 324a and the perforations 324b, as indicated by the
fluid flow arrows 326. All or part of the screen/suture system 302
can comprise absorbable material.
FIGS. 12, 13a and 13b show a modified embodiment screen-only
closure screen system 402 and application methodology. A screen or
mesh 404, similar to the screen 14 with barbed strands 30 described
above, is placed in a separation 4 against the first tissue portion
12a. The second tissue portion 12b is then placed against the
screen 404 whereby the separation 4 is closed and can be secured by
the mechanical action of the screen 404. The screen 404 can be
supplemented with sutures, drainage tubing, I/O devices, and other
auxiliary components for purposes of closing the wound edges 12,
draining the inside of the tissue separation 4, fighting infection,
pain management and all other functionalities associated with the
present invention, as discussed elsewhere herein. For example, the
screen 404 can be secured with sutures at the subcutaneous level 8.
Various fluid interconnecting devices can be utilized as necessary,
and can be designed for removal after they serve their initial
purpose. External drainage can also be achieved at the dermis level
6 utilizing transfer element subassemblies, such as the example
designated 59 and described above (FIG. 7d). Moreover, drainage and
irrigation tubing can be installed within the wound 4 alongside or
adjacent to the screen 404. It will be appreciated that a
screen-only version of the invention can comprise various suitable
biocompatible absorbable and non-absorbable materials, including
the materials disclosed above.
FIG. 13a is an enlarged view of the screen 404 and particularly
shows barbed strands 406 and horizontal spacers 408, which are
connected together in a grid pattern forming the screen 404. FIG.
13b shows an alternative embodiment with a modified screen 410
including vertical risers 412 comprising hollow tubing, which are
connected to and spaced by horizontal spacers 408. Fluid flows into
and out of the vertical risers 412 through open riser ends 412a and
perforations 412b, as indicated by the fluid flow arrows 420.
FIGS. 14a-g show the screen 404 installed in a tissue separation 4
and closing same, utilizing the methodology of the present
invention. The methodology shown in FIGS. 14a-g is similar to the
methodology shown in FIGS. 5a-e and 6a,b. FIG. 14c shows a
downward/inward force arrow 54a indicating a direction in which the
screen 404 is pushed or guided into the separation.
FIGS. 15a,b and 16a,b show a modified vertical riser 502 comprising
bundled tubes 504 secured together at spaced intervals by
connectors 506. The normal movement of the patient tends to
alternately compress and expand the vertical risers 502, thus
providing a "pumping" action for transferring fluid from the wound
4, as indicated by the fluid flow arrows 510. FIGS. 15a,b show a
riser 502 in an extended configuration. Compressing the screen 14
longitudinally (i.e., end-to-end) compresses the bundled risers 504
to the configuration shown in FIGS. 16a,b, whereby fluid is drawn
into the interstitial space 508 and pumped therefrom when the
risers 502 extend.
FIG. 17 shows yet another configuration of a vertical riser 602
with bundled tubes 604, which are closely bunched and define
passages 606 for conveying fluid. Such fluid conveyance can be
enhanced by a pumping action associated with normal patient
movements. Barbs 608 project outwardly from the tubes 604. It will
be appreciated that various other bundled tube configurations, such
as twisted, braided, etc., can be utilized.
FIG. 18 shows yet another vertical riser/perimeter member 702
alternative embodiment configuration. The member 702 has a
configuration which is commonly referred to as a "fluted" drain and
includes longitudinally-extending passages 704. This configuration
can substitute for the perimeter members described above and can
function to communicate fluid to and from the wound 4 with the
input/output subsystem 18.
As additional alternative embodiment configurations for the
vertical risers, they can comprise either barbed monofilament
strands, similar to strand 30 shown in FIG. 3, or unbarbed
monofilament strands. Such monofilament vertical risers can
function as passive drains with fluid flowing alongside same. They
can extend above the dermis 6 and abut or connect to transfer
elements formed in various configurations with suitable absorbent
materials. Examples include gauze dressings and transfer element
subassemblies, such as 59 shown in FIG. 7d.
FIG. 19 shows an alternative embodiment strand 802 constructed by
twisting and braiding multiple, individual filaments 804. Barbs 805
are formed by respective individual filaments 804a, which terminate
at blunt ends 806. The barbs 805 project generally outwardly from
the strand 802 and form acute angles with respect to its
longitudinal axis. They are adapted for penetrating tissue within a
separation 4, as described above. In use, the barbs 805 would
normally be oriented in directions generally pointing outwardly
from the patient and the tissue separation 4.
FIG. 20 shows another alternative embodiment strand 902 comprising
multiple twisted and braided filaments 904. Barbs 905 are formed
from individual filaments 904a and have notches 908 and pointed
ends 910. The notches 908 and the ends 910 are configured to allow
the barbs 905 to easily extract from the separation edge tissues,
whereby the screen is adapted for sliding along the separation
edges in order to achieve the proper position.
FIG. 21 shows a further modified screen 1002 with barbs 1004 formed
by looping individual filaments 1006 and cutting same at cut
locations 1010 spaced inwardly from respective apexes 1008 of the
filament loops. In operation, the barbs 1004 slightly penetrate the
tissue and are imbedded therein. It will be appreciated that the
filaments 1006 are relatively thin in diameter, similar to
microfibers, whereby patient comfort is optimized.
FIG. 22 shows yet another modified screen 1102 with barbs 1104
formed by looping individual filaments 1106 and cutting same at
locations 1110 spaced inwardly from respective apexes 1108 of the
filament loops whereby respective hooks 1112 are formed. The hooks
1112 operate in a manner similar to hook-and-loop fasteners, with
the adjacent tissue forming the loop parts of the connections. In
operation, the hooks 1112 slightly penetrate the tissue and are
imbedded therein. The configurations of the hooks 1112 tend to
retain them in the tissue adjacent to the separation 4 whereby the
separated first and second tissue portions 12a,b can be closed.
FIG. 23 shows a screen 1202 with a configuration similar to the
screen 1002 discussed above, with additional fiber elements or
filaments 1204. The additional filaments 1204 tend to lay the
filament barbs 1206 over whereby the screen 1202 can be
directionally oriented within the wound separation 4 and operate in
a manner similar to the screen 14 described above. The barbs 1206
are formed by cutting the apexes 1208 at cut locations 1210.
Similarly, FIG. 24 shows a screen 1302 with additional filaments
1304, which engage the filament loops 1306 and orient same in a
direction towards the right as shown in FIG. 24. The slanted
orientations of the filament loops 1306 facilitate setting same in
the tissue portions 12a,b adjacent to the separation 4 by tugging
outwardly on the screen 1302. Repositioning the screen 1302 is also
possible, as described above. The filament loops 1306 can be cut at
cut locations 1310, which are spaced inwardly from filament loop
apexes 1308 whereby hooks 1312 are formed.
It will be appreciated that FIGS. 21-24 disclose screens with barbs
and hooks extending from one face thereof. The present invention
also includes screens with barbs and hooks extending from both
faces.
A closure screen comprising a further modified aspect or embodiment
of the invention is shown in FIGS. 25-30 and is generally
designated by the reference numeral 1402. The screen 1402 generally
comprises a highly flexible panel 1404, which engages and
approximates adjacent tissue portions across a separation by the
semi-independent action of multiple, individual clips comprising
links 1440 (FIG. 25a), which are strung together in respective
strands 1408 by suitable flexible filaments or lines 1446. As shown
in FIG. 25a, each link 1440 includes a pair of prongs 1442 medially
joined by a loop 1444, to which the filament 1446 can be tied or
otherwise secured. The loop 1444 thus forms a pivot point or
fulcrum with the filament 1446 whereby a rocking action of the link
1440 is facilitated. For example, relative movement of the screen
1402 and the surrounding tissue can impart a torque force, as
represented by a torque arrow 1448. The torque force rotates the
clip 1440 to a tilted position, as shown by the broken lines in
FIG. 25a. Such a rocking action can advance the prongs into the
surrounding tissue, thereby enhancing closure. Moreover, relative
movement of the surrounding tissue can be accommodated by the
combination of screen flexibility and prong movement. Fixation and
tissue movement can be variably controlled somewhat by varying the
design of the screen 1402 and the clips 1440.
FIGS. 26 and 27 show an alternative configuration link 1406 with a
first prong 1410 and a second prong 1412, which terminate at
pointed, sharpened first and second prong ends 1414, 1416
respectively and are joined by a link body 1413. A link 1417 with a
slightly different, more open configuration is shown in FIG. 27a.
As shown in FIG. 28, the prongs 1410, 1412 of the link 1406 extend
generally outwardly from the body 1413 and generally longitudinally
with respect to a longitudinal axis 1418 of a strand 1408, and form
opposite, acute angles therewith. The angular orientations of the
prongs 1410, 1412 provide a one-way orientation for engagement in a
first direction and a disengagement orientation in the opposite
direction. Each link 1406 can be integrally formed from a single
length of suitable, suture-like material with suitable memory,
flexibility/rigidity and biocompatibility characteristics. A
U-shaped loop 1420 is formed between the prongs 1410, 1412.
Also as shown in FIG. 28, each loop 1420 receives a respective long
prong 1410 from the adjacent link 1406 in a flexible engagement,
which can be formed by thermal fusing, ultrasonic welding, adhesive
or any other suitable fastening device or method. For example, the
link prongs 1410 and the loops 1420 can be configured for the
tongue-and-groove or snap-fit, movable interconnection without the
necessity of physically bonding the links 1406.
The strands 1408 can be secured together in forming the panel 1404
by multiple, diagonal filaments 1422, which extend generally
transversely, horizontally, longitudinally or, preferably,
diagonally with respect to the panel 1404. Like the links 1406,
1417 and 1440, the filaments 1422 can comprise a bioabsorbable or
other biocompatible material. The filaments 1422 are preferably
highly flexible and thin. FIG. 29 shows the screen panel 1404 in a
compressed configuration whereby the first, long prongs 1410 are
pivotably received within the respective loops 1420 of adjacent
links 1406. FIG. 30 shows such pivotal action of the links 1406
(dashed lines) for accommodating relative tissue movement on either
side of the tissue separation
The screen 1402 includes a pre-installation enclosure assembly 1424
comprising front and back backing sheets 1426, 1428, which can be
provided with a suitable releasable adhesive 1429. The backing
sheets 1426, 1428 preferably comprise paper or other material
(e.g., Styrofoam.RTM. material), which is relatively stiff (as
compared to the relatively flimsy panel 1404) for maintaining the
flat shape of the closure screen 1402 during handling and placement
in the patient and for protection from the sharpened prong tips. An
outer edge handling strip 1430 is mounted on the upper edge of
perimeter 1432 of the panel 1404 (FIG. 25) and is adapted for
grasping manually or with instruments in order to facilitate
handling, alignment and placement.
An alternative embodiment or aspect of the present invention is
shown in FIGS. 31-33 and includes a modified clip comprising a
dual-loop link 1556. Each link 1556 includes first and second
prongs 1560, 1562 terminating at respective first and second ends
1564, 1566. Proximal and distal loops 1570, 1571 are provided
adjacent to first and second prongs 1560, 1562 respectively.
FIG. 34 shows a modified closure screen construction 1624 using the
clips 1604 mounted on a flexible matrix 1626 comprising flexible
strips 1628 flexibly interconnected in parallel relation by cross
strands 1630. The strips 1628 can be penetrated by the prongs 1614,
1616 whereby all of the clips 1604 can be mounted on one side of a
two-sided closure screen 1624. Alternatively, clips 1604 can be
mounted on both sides of the strips 1628 in a two-sided closure
screen, or on either side with all of the prongs pointing out for a
single-sided closure screen.
FIG. 34a shows alternative clip constructions. Clip 1632 has
interior prongs 1614 and edge prongs 1616 extending from one face
at the top and from the other face at the bottom. Clip 1634 has
upper prongs 1614, 1616 extending from opposite faces, and lower
prongs 1614, 1616 likewise extending from opposite faces. Clip 1636
includes only one each interior prong 1614 and edge prong 1616,
which can extend outwardly from the same face (as shown), or can
extend outwardly from opposite faces.
FIG. 35 shows a clip 1632 approximating a tissue separation 4. The
respective prongs 1614, 1616 are embedded in the opposed tissue
portion edges 12a,b. Relative movement of the tissue can further
secure the prongs 1614, 1616, whereby the edges 12a,b are drawn
together for healing.
FIGS. 36 and 37 show a closure screen 1602 comprising another
aspect or embodiment with multiple, independent rigid clips 1604 on
a flexible mesh matrix 1606. Each clip 1604 includes first and
second faces 1608, 1610 and a perimeter 1612. Interior prongs 1614
are punched out of the clip 1604, thereby forming clip openings
1615, and perimeter prongs 1616 are punched out adjacent to the
perimeter 1612, thereby forming notches 1618. The closure screen
1602 is formed by threading mesh material connector strands 1620
through the clip openings 1615, and securing the strands 1620
together in a crisscross pattern as shown in FIG. 36. The clips
1604 can be alternatingly oriented such that their respective
prongs 1614 and 1616 extend from both sides of the screen 1602 (as
shown) for two-sided engagement, or they can extend from one face
only for single-sided engagement.
FIG. 38 shows several constructions of clips 1852, 1858, 1864 and
1870, stamped from sheet metal or other suitable material and
having respective bodies comprising bases 1854, 1860, 1866 and 1872
with sharpened, respective prongs 1856, 1862, 1868 and 1874
projecting therefrom. FIG. 39 shows yet another clip construction
1876 placed in a woven screen or mesh structure 1878, such as those
described above, generally coplanar with a clip base 1880. Each
clip 1876 has a pair of prongs 1882 projecting outwardly therefrom.
The clips 1852, 1858, 1864 and 1870 are adapted for attachment to
such screen or mesh structures, resulting in configurations as
shown in FIGS. 40-43.
FIGS. 44-49 show different bent-wire clip constructions adapted for
mounting on flexible screen or mesh structures. A clip 1802 with a
generally rectangular base 1804 and a single prong 1806 projecting
outwardly therefrom is shown in FIGS. 44 and 47. FIGS. 45 and 48
show a variant clip 1808 with a generally rectangular base 1810 and
prongs 1812. FIGS. 46 and 49 show another variant clip 1814 with a
generally U-shaped base 1816 and a pair of prongs 1818 projecting
outwardly therefrom. The bases 1804, 1810 and 1818 are adapted to
lie generally in a plane formed by the screen or mesh structure,
with the prongs 1806, 1812 and 1818 projecting outwardly therefrom
at suitable acute angles, such as about 30-45 degrees. The prongs
can have sharpened tips, as shown.
FIG. 50 shows a clip 1902 comprising another alternative embodiment
clip configuration. As shown in FIGS. 51a-c, clip configurations
1902a-c can be formed with four each primary prongs 1904 and four
each secondary prongs 1906, which can extend from one or both faces
of a body 1908 of a respective clip 1902. FIGS. 52a-c show side
elevations of the clip configurations 1902a-c. A center slot 1903
is formed in the body 1908 and notches 1905 are formed around its
perimeter. The center slot 1903 and the notches 1905 are adapted to
receive filaments or other flexible members in a closure screen
matrix including multiple clips 1902, whereby the clips 1902 can be
somewhat fixed in position in a flexible closure screen
construction.
FIGS. 53 and 53a show another alternative embodiment clip
configuration 1910 with curved primary prongs 1912 and straight
secondary prongs 1914. The curvature of the primary prongs 1912
facilitates drawing the separated tissue portions 12a, 12b
together, as shown in FIG. 53a and as presented by the lateral
force arrows 1916. Such lateral forces can be applied with a NPWT
device, such as The V.A.C..RTM. System.TM. manufactured by Kinetic
Concepts, Inc. of San Antonio, Tex. The secondary prongs 1914 help
prevent disengagement when the closure screen is subjected to a
downward (i.e. into the body) force as represented by a force arrow
1917.
FIGS. 54 and 54a show another alternative embodiment clip
configuration with a curved body 1922. The configuration causes a
trailing primary prong 1924 to engage and penetrate tissue first,
whereafter the clip 1920 rotates, embedding a leading primary prong
1926. The torque (clockwise as shown by torque arrow 1927) imparted
to the clip 1920 by a tugging force, for example along the force
arrow 1928 on an encircling filament 1929, tends to facilitate
secure anchorage in tissue 12b.
FIGS. 55 and 55a show another alternative embodiment
clip-configuration 1930 with flexible, collapsible prongs 1932,
1934, which are collapsed when the clips are between backing
screens 1936a,b. When the backing screens 1936a,b are removed (FIG.
55a), the prongs 1932, 1934 spring outwardly to extended
orientations and are adapted for penetrating the tissue 12b.
The alternative configuration clips 1910, 1920 and 1930 can be
formed from a common clip template, such as that shown at 1902 in
FIG. 50, with a bendable body and prongs adapted for bending into
various desired configurations. Moreover, the clips can be mounted
in various screen matrices.
FIG. 56 shows another alternative embodiment clip configuration
1940 with primary and secondary prongs 1942, 1944 having respective
barbs 1942a, 1942b. FIG. 57 shows another alternative embodiment
clip configuration 1950 with primary and secondary prongs 1952,
1954 having respective barbs 1952a, 1952b. FIG. 58 shows another
alternative embodiment clip configuration 1960 with quadrilateral
primary and secondary prongs 1962, 1964 having respective
trocar-shaped ends 1962a, 1964a. Various other clip, base and prong
configurations, combinations and orientations can be utilized with
the present invention.
FIG. 59 shows a closure clip system 1970 comprising another
alternative embodiment of the present invention. The system 1970
includes a screen 1972, which can comprise, for example, any of the
clip and screen constructions described above. The screen 1972 is
placed within the tissue separation 4 and an extension 1974 is
folded over onto the skin surface on either or both sides of the
tissue separation 4. Affixing the screen, or the strips comprising
same, helps to support the links and clips in position against
downward loads. The adhesive on the screen or strips would not
adhere to the wet tissue of the separation edges, but would appear
to the dry skin surface 6. The screen or strips can be made of
rapidly dissolving, bioabsorbable material reinforced with
longitudinal strands of slower dissolving material, similar to the
construction of strand reinforced tape available as
STERI-STRIP.RTM. from the 3M Company of St. Paul, Minn. With the
extension 1974 folded over the skin surface 6 and the rest of the
clips above the wound 4 removed or cut away, the extension(s) 1974
can be affixed to the skin surface 6 with STERI-STRIP or some other
suitable tape 1976. In lieu of-or in addition to the tape 1976,
surgical staples 1978 can be used to close the tissue separation
and affix the extension(s) 1974 to the skin surface 6. Lateral
closure forces can optionally be applied to the tissue separation 4
shown in FIG. 59 by applying a NPWT source 1980 such as The
V.A.C..RTM. System.TM. over the closure. A suitable drape 1982 can
be applied over the negative pressure source 1980 in sealing
relation with the skin around the perimeter.
FIG. 60 shows a load-deformation curve showing the relationship of
tension measured in pounds per prong and extension of the system
measured in sixteenths of an inch using a multiple-clip screen
similar to the closure screen 1602 shown in FIG. 36. The screen was
retained between two pieces of raw beefsteak, which were subjected
to varying shear stress (tensile) forces, as plotted on the Y axis
of the graph in FIG. 60. Compression forces equal to 0.341
pounds/prong were applied to the beefsteak pieces with the closure
screen clamped therebetween. Such compression forces were applied
mechanically to produce the load-deformation curve shown in FIG.
60. FIG. 61 shows a load-deformation curve for varying compression
forces at a constant tension force of 0.341 pounds/prong. A
theoretical point projected from the load-deformation curve of FIG.
61 represents 100 mmHg of vacuum compression, as applied with The
V.A.C..RTM. System.TM. in the model tested. FIG. 60 shows that
increasing tension loads produce increasing extension of the model
(positive relationship). FIG. 61 shows that compression loads and
extension have an inverse relationship, with greater extension
occurring with lesser compression loads.
It is to be understood that while certain forms of the present
invention have been illustrated and described herein, it is not to
be limited to the specific forms or arrangement of parts described
and shown.
* * * * *